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Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs (IDOLTIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04034862
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gilles Darcis, University of Liege

Brief Summary:

For a few years, there has been a keen interest of clinicians and patients for "lighter" antiretroviral strategies based on two- or even single drug regimens rather than the canonical triple therapy, both as initial and maintenance therapy, despite the possibility that ongoing viral replication may occur in some patients under triple-therapy.

We will therefore propose such simplification strategy (DTG/3TC) while maintaining triple-therapy (DTG/ABC/3TC) in a control group and will perform an in depth analysis of the replication-competent reservoir in blood and in tissues as well as measurements of residual viremia and immune chronic activation/inflammation.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Treatment simplification (dolutegravir lamivudine) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 2DR
Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)
Drug: Treatment simplification (dolutegravir lamivudine)
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

No Intervention: 3DR
Continued 3 drug regimen treatment (DTG+ABC+3TC)



Primary Outcome Measures :
  1. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues. [ Time Frame: 1 year ]
    Measurements of RCR in the blood and tissues (rectal biopsies)


Secondary Outcome Measures :
  1. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia. [ Time Frame: 1 year ]
  2. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation. [ Time Frame: 1 year ]
  3. The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy. [ Time Frame: 1 year ]
  4. The level of clonal expansion in the blood and tissue RCR [ Time Frame: 1 year ]
  5. The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected adults receiving cART for at least 2 years
  • DTG/3TC/ABC as cART regimen in the previous 6 months.
  • CD4 counts higher than 200 cells per μL and virological suppression for at least 2 years (plasma HIV RNA <20 copies per mL)

Exclusion Criteria:

  • hepatitis C or B co-infection
  • unstable liver disease
  • renal impairment (estimated glomerular filtration rate <50 mL per min),
  • gastrointestinal disorders that would affect the absorption of study treatment
  • current use of drugs with significant interactions with dolutegravir
  • current use of drugs with an impact on inflammation such as steroids.
  • hospitalization for acute illness within the previous 8 weeks
  • Pregnancy or breastfeeding.
  • Known resistance to DTG or 3TC
  • Active tuberculosis
  • Anal or rectal lesions impeding rectal biopsies
  • Decreased platelets count or coagulation disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034862


Contacts
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Contact: Gilles Darcis +3243667235 ext +3243667235 gdarcis@chuliege.be
Contact: Michel Moutschen +3243667235 ext +3243667235 michel.moutschen@ulg.ac.be

Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Gilles Darcis, MD PhD Liege University Hospital

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Responsible Party: Gilles Darcis, Head of clinic, University of Liege
ClinicalTrials.gov Identifier: NCT04034862    
Other Study ID Numbers: 13011987
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Dolutegravir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors